60 Participants Needed

PSMA-PET Scan for Prostate Cancer

AF
RS
Overseen ByRiley Smith
Age: 18+
Sex: Male
Trial Phase: Phase 2 & 3
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that you should not have had any radioisotope treatments recently, so it's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug F-DCFPyL Injection, Pylarify, 18F-DCFPyL for prostate cancer?

Research shows that the drug 18F-DCFPyL is effective in detecting prostate cancer lesions better than traditional imaging methods like CT scans and bone scans. It has been tested in major trials, such as OSPREY and CONDOR, which demonstrated its usefulness in staging and managing prostate cancer.12345

Is the PSMA-PET Scan using 18F-DCFPyL safe for humans?

The PSMA-PET Scan using 18F-DCFPyL, also known as Pylarify, has been tested in multiple major trials and is approved by the U.S. Food and Drug Administration for use in prostate cancer imaging. While the studies focus on its effectiveness, the approval suggests it has been deemed safe for human use in the context of these trials.24678

How does the PSMA-PET scan treatment for prostate cancer differ from other treatments?

The PSMA-PET scan using [18F]DCFPyL is unique because it targets a specific protein found in high amounts on prostate cancer cells, allowing for more precise imaging compared to traditional methods like CT or bone scans. This can help in better detecting and managing prostate cancer, especially in cases where the cancer has spread.125910

Research Team

Kosj Yamoah | Moffitt

Kosj Yamoah, MD

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria

Men over 18 with high-risk prostate cancer, as indicated by a Decipher test score greater than 0.45, who were part of a previous study (MCC#18523) and have had either surgery or radiation therapy for their cancer. They must be in good physical condition (ECOG status 0-1) and have at least two years of follow-up data post-treatment.

Inclusion Criteria

My biopsy or surgical sample has undergone genomic testing.
I am older than 18 years.
My Decipher score is above 0.45, indicating high risk.
See 3 more

Exclusion Criteria

No follow up information available post treatment
Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
I haven't had certain types of scans or contrasts recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive F-DCFPyL PSMA PET imaging to detect recurrent/metastatic prostate cancer

Annually for 4 years
1 visit per year (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

5 years

Treatment Details

Interventions

  • F-DCFPyL Injection
Trial OverviewThe trial is testing PSMA-PET imaging using F-DCFPyL injection to detect early metastatic prostate cancer in men with high genomic classifier scores from an earlier study. The goal is to see how well this imaging technique works for those at higher risk.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Radioactive Diagnostic ImagingExperimental Treatment2 Interventions
Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials
35
Recruited
4,400+

Findings from Research

The study demonstrated that the 18F-DCFPyL PET imaging can effectively distinguish malignant prostate cancer from benign tissue, with significant differences in uptake values observed as early as 5 minutes post-injection in 10 patients with high-risk prostate cancer.
The pharmacokinetic analysis revealed that malignant prostate tissue had a 15-fold higher influx value (Ki) compared to benign prostatic hyperplasia and normal prostate tissue, indicating that 18F-DCFPyL PET imaging can be a valuable tool for early detection of prostate cancer.
A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients.Lu, M., Lindenberg, L., Mena, E., et al.[2023]
The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.
Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.
[18F]DCFPyL PET/CT for Imaging of Prostate Cancer.Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]
The automated synthesis of the radiotracer [(18)F]DCFPyL for PET imaging of prostate cancer was successful, yielding a good radiochemical yield of 23% in just 55 minutes, making it suitable for clinical applications.
[(18)F]DCFPyL demonstrated high uptake in PSMA-positive LNCaP tumors, with a two-step molecular trapping mechanism confirmed, indicating its potential effectiveness for targeted imaging in prostate cancer.
Automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models.Bouvet, V., Wuest, M., Jans, HS., et al.[2020]

References

A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients. [2023]
[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]
Automated synthesis of [(18)F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models. [2020]
Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023]
PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]
Prospective Evaluation of 18F-DCFPyL PET/CT in Biochemically Recurrent Prostate Cancer in an Academic Center: A Focus on Disease Localization and Changes in Management. [2020]
Piflufolastat F 18: Diagnostic First Approval. [2022]
Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]
Prospective intraindividual comparison of 18F-PSMA-7Q and 18F-DCFPyL PET/CT in patients with newly diagnosed prostate cancer. [2023]
Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]